Pharmaceutical Technology Europe - October 2010 - (Page 9)

Achieving more effective cell culture with single-use systems One of the many benefits of using single-use systems for cell culture versus traditional systems is the shorter time to establish a facility. This allows the sponsor to delay the building of a dedicated facility until later in the product development phases, therefore providing peace Figure 1: Impact of decision time. Project Survival % 100% of mind if the product fails clinical testing. It also gives the manufacturer more time to gain greater knowledge about the manufacturing process. Figure 1 shows the advantages of having the option to postpone the building of a new facility for a specific product. Morten Mu nk Research Development Market Clinical Trials I,II,III & Registration 50% 40 month project: 50% chance of being needed 24 month project: 90% chance of being needed 10% Shorter project period signiﬁcantly reduces project risk 8% Reducing project duration by 16 months reduces chance of the wrong investment being made by a factor of 5 Despite the advantages of single-use systems, however, there are also challenges to incorporating them into cell culture production facilities. In particular, they involve expensive materials, such as chromatographic resins. Such issues can, to some extent, be mitigated using the single-use system for several batches; however, single-use system reuse or campaigning is very controversial since the whole idea of single-use systems is, as the name suggests, that the system is only used once. One of the most predominant challenges, however, is the perception and conservatism of single-use systems from the authorities, as well as from manufacturers who have already invested heavily in conventional systems. This can only be overcome by information and support, and a willingness to implement single-use systems. PTE Based on a contribution by Morten Munk, Vice President, Business Development, CMC Biologics A/S. To read the full version of this article, go to www.pharmtech.com/munk www.cmcbio.com 1 CONTENTS 8 MATERIAL COMPATIBILITY 3 HARNESSING THE ADVANTAGES 10 SINGLE-USE BIOREACTORS 6 CMO ADOPTION 11 QUALITY AGREEMENT TEMPLATE 7 VALIDATION 12 TOP TECHNOLOGIES http://www.pharmtech.com/munk http://www.cmcbio.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - October 2010

Table of Contents
Pharmaceutical Technology Europe - October 2010
Our Survey Says...
Harnessing the Advantages of Single-Use Systems
Should You Implement Single-Use Systems?
CMO Industry Adoption of Single-Use Technology
Validating Single-Use Systems
Material Compatibility and Single Use Systems
Achieving More Effective Cell Culture with Single-Use Systems
The Pros and Cons of Single-Use Bioreactors
Developing a Quality Agreement Template for Single-Use Systems
Ten Top Single-Use Technologies Showcased

Pharmaceutical Technology Europe - October 2010